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Clinical Trial Results:
A Phase II, Multicenter, Randomized, Double Masked, Active Comparator-controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients With Diabetic Macular Edema

Summary
EudraCT number	2021-003756-16
Trial protocol	ES CZ PL
Global end of trial date	21 Apr 2025

Results information
Results version number	v1(current)
This version publication date	03 May 2026
First version publication date	03 May 2026
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

BP43445

ISRCTN number

US NCT number

NCT05151731

WHO universal trial number (UTN)

Sponsor organisation name

F. Hoffmann-La Roche AG

Sponsor organisation address

Grenzacherstrasse 124, Basel, Switzerland, CH-4058

Public contact

F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com

Scientific contact

F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

21 Apr 2025

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

21 Apr 2025

Was the trial ended prematurely?

Main objective of the trial

The main aim of the study was to evaluate the effects of vamikibart on visual function by assessing changes from baseline in best-corrected visual acuity (BCVA) in treatment-naïve participants with diabetic macular edema (DME).

Protection of trial subjects

All study subjects were required to read and sign an Informed Consent Form (ICF).

Background therapy

Evidence for comparator

Actual start date of recruitment

31 Dec 2021

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 231

Country: Number of subjects enrolled

Poland: 16

Country: Number of subjects enrolled

Korea, Republic of: 16

Country: Number of subjects enrolled

United Kingdom: 11

Country: Number of subjects enrolled

Spain: 12

Country: Number of subjects enrolled

Czechia: 25

Country: Number of subjects enrolled

Canada: 9

Country: Number of subjects enrolled

Argentina: 74

Worldwide total number of subjects

394

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

215

From 65 to 84 years

179

85 years and over

Subject disposition

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Recruitment details

A total of 394 participants with DME took part in the study at 74 investigative sites across Argentina, Canada, Czech Republic, Spain, Republic of Korea, Poland, the United Kingdom and the United States from 31 December 2021 to 21 April 2025.

Screening details

Participants were randomized into 1:1:1:1 ratio to 4-parallel arms- 0.25 milligrams (mg) Vamikibart every 8th week (Q8W), 1 mg Vamikibart Q8W, 1 mg Vamikibart every 4th week (Q4W), and 0.5 mg Ranibizumab Q4W, to receive treatment up to Week 44, followed by off-treatment observation.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

Arm A: Vamikibart 0.25 mg Q8W

Arm description

Participants received vamikibart, 0.25 mg, intravitreal (IVT) injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.

Arm type

Experimental

Investigational medicinal product name

Vamikibart

Investigational medicinal product code

RO7200220

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

Vamikibart, 0.25 mg, by IVT injection, on Day 1 and Q8W up to Week 44.

Arm B: Vamikibart 1 mg Q8W

Arm description

Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.

Arm type

Experimental

Investigational medicinal product name

Vamikibart

Investigational medicinal product code

RO7200220

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

Vamikibart, 1 mg, by IVT injection, on Day 1 and Q8W up to Week 44.

Arm C: Vamikibart 1 mg Q4W

Arm description

Participants received vamikibart, 1 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.

Arm type

Experimental

Investigational medicinal product name

Vamikibart

Investigational medicinal product code

RO7200220

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

Vamikibart, 1 mg, by IVT injection, on Day 1 and Q4W up to Week 44.

Arm D: Ranibizumab 0.5 mg Q4W

Arm description

Participants received ranibizumab, 0.5 mg, IVT injection in the specified study eye on Day 1 and Q4W for a total of 12 injections up to Week 44. After Week 44, participants were followed for safety up to Week 72.

Arm type

Active comparator

Investigational medicinal product name

Ranibizumab

Investigational medicinal product code

Other name

Lucentis

Pharmaceutical forms

Solution for injection

Routes of administration

Intravitreal use

Dosage and administration details

Ranibizumab, 0.5 mg, by IVT injection, on Day 1 and Q4W up to Week 44.

Number of subjects in period 1	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Started	95	101	98	100
Safety-evaluable Population	94	100	98	98
Treatment-naïve Intent-to-treat (ITT)	65	65	64	65 ^[1]
Previously Treated ITT Population	30 ^[2]	36 ^[3]	34 ^[4]	35 ^[5]
Completed	57	64	64	84
Not completed	38	37	34	16
Physician decision	1	2	4	-
Consent withdrawn by subject	6	3	6	6
Adverse Event	8	9	9	3
Death	1	1	1	1
Reason Not Specified	6	11	6	2
Non-compliance With Study Drug	-	-	1	1
Lost to follow-up	3	1	4	3
Need for Rescue Treatment	11	10	1	-
Protocol deviation	2	-	2	-

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants in the respective analysis population are presented here.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants in the respective analysis population are presented here.
[3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants in the respective analysis population are presented here.
[4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants in the respective analysis population are presented here.
[5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants in the respective analysis population are presented here.

Baseline characteristics

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Reporting group title

Arm A: Vamikibart 0.25 mg Q8W

Reporting group description

Reporting group title

Arm B: Vamikibart 1 mg Q8W

Reporting group description

Reporting group title

Arm C: Vamikibart 1 mg Q4W

Reporting group description

Reporting group title

Arm D: Ranibizumab 0.5 mg Q4W

Reporting group description

Reporting group values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W	Total
Number of subjects	95	101	98	100	394
Age categorical
Units: Subjects
Age Continuous
Units: years
arithmetic mean (standard deviation)	64.2 ( 9.8 )	63.2 ( 10.0 )	62.8 ( 8.7 )	59.8 ( 9.8 )	-
Sex: Female, Male
Units: participants
Female	51	45	43	45	184
Male	44	56	55	55	210
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	2	1	1	0	4
Asian	5	6	5	6	22
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	10	6	6	6	28
White	36	45	49	50	180
More than one race	0	0	0	0	0
Unknown or Not Reported	42	43	37	38	160
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	15	14	10	8	47
Not Hispanic or Latino	42	47	54	55	198
Unknown or Not Reported	38	40	34	37	149

End points

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Reporting group title

Arm A: Vamikibart 0.25 mg Q8W

Reporting group description

Reporting group title

Arm B: Vamikibart 1 mg Q8W

Reporting group description

Reporting group title

Arm C: Vamikibart 1 mg Q4W

Reporting group description

Reporting group title

Arm D: Ranibizumab 0.5 mg Q4W

Reporting group description

Primary: Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Treatment-naïve Participants

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End point title

Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Treatment-naïve Participants

End point description

BCVA was measured at a starting test distance of 4 meters (m) for both eyes, prior to dilation by using set of three Precision visionTM or Lighthouse distance acuity charts (modified early treatment diabetic retinopathy study [ETDRS] charts 1, 2 and R) by trained & certified personnel at study sites at each study visit. BCVA letter score ranges from 0-100 (best score attainable), & gain in BCVA letter score from baseline indicates improved visual acuity. This analysis used a Mixed Model for Repeated Measurements (MMRM) model. Adjusted mean has been reported. Treatment-naïve ITT population=all randomized participants who were naïve to IVT anti-vascular endothelial growth factor (VEGF) or periocular/IVT corticosteroids treatment. Participants were grouped according to treatment assigned at randomization.

End point type

Primary

End point timeframe

Baseline, Weeks 44 and 48

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	65	65	64	65
Units: ETDRS letters
arithmetic mean (standard error)	7.1 ( 1.28 )	4.6 ( 1.26 )	5.5 ( 1.29 )	13.0 ( 1.26 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0012

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-5.9

Confidence interval

level

90%

sides

2-sided

lower limit

-8.9

upper limit

-3

Variability estimate

Standard error of the mean

Dispersion value

1.79

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-8.4

Confidence interval

level

90%

sides

2-sided

lower limit

-11.3

upper limit

-5.4

Variability estimate

Standard error of the mean

Dispersion value

1.78

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

129

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-7.5

Confidence interval

level

90%

sides

2-sided

lower limit

-10.5

upper limit

-4.5

Variability estimate

Standard error of the mean

Dispersion value

1.8

Secondary: Number of Participants With Systemic and Ocular Adverse Events (AEs)

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End point title

Number of Participants With Systemic and Ocular Adverse Events (AEs)

End point description

An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs include all non-ocular AEs. Only one eye was selected as the study eye, while the other was referred to as the fellow eye. Safety analysis population included all participants randomized to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not. Participants were grouped according to the actual treatment received.

End point type

Secondary

End point timeframe

Up to Week 72

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	94	100	98	98
Units: participants
Systemic AEs	43	58	54	65
Ocular AEs in Study Eye	39	46	41	31
Ocular AEs in Fellow Eye	13	25	24	29

No statistical analyses for this end point

Secondary: Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants

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End point title

Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants

End point description

The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. Previously treated ITT population included all randomized participants who were previously treated with IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization.

End point type

Secondary

End point timeframe

Baseline, Weeks 44 and 48

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	30	36	34	35
Units: ETDRS letters
arithmetic mean (standard error)	2.0 ( 2.74 )	-0.5 ( 2.39 )	-0.4 ( 2.49 )	9.6 ( 2.21 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.034

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-7.6

Confidence interval

level

90%

sides

2-sided

lower limit

-13.4

upper limit

-1.7

Variability estimate

Standard error of the mean

Dispersion value

3.52

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0027

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-10.1

Confidence interval

level

90%

sides

2-sided

lower limit

-15.5

upper limit

-4.7

Variability estimate

Standard error of the mean

Dispersion value

3.26

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0036

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-10

Confidence interval

level

90%

sides

2-sided

lower limit

-15.5

upper limit

-4.4

Variability estimate

Standard error of the mean

Dispersion value

3.32

Secondary: Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population

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End point title

Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population

End point description

The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. Overall ITT population included all randomized participants.

End point type

Secondary

End point timeframe

Baseline, Weeks 44 and 48

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	95	101	98	100
Units: ETDRS letters
arithmetic mean (standard error)	5.2 ( 1.19 )	3.3 ( 1.13 )	3.8 ( 1.16 )	11.7 ( 1.09 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

195

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-6.5

Confidence interval

level

90%

sides

2-sided

lower limit

-9.2

upper limit

-3.8

Variability estimate

Standard error of the mean

Dispersion value

1.61

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

201

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-8.4

Confidence interval

level

90%

sides

2-sided

lower limit

-11

upper limit

-5.8

Variability estimate

Standard error of the mean

Dispersion value

1.57

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

198

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-7.9

Confidence interval

level

90%

sides

2-sided

lower limit

-10.5

upper limit

-5.2

Variability estimate

Standard error of the mean

Dispersion value

1.59

Secondary: Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants

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End point title

Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants

End point description

The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. Treatment-naïve ITT population included all randomized participants who were naïve to IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization.

End point type

Secondary

End point timeframe

Baseline, Weeks 32 and 36

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	65	65	64	65
Units: ETDRS letters
arithmetic mean (standard error)	5.8 ( 1.24 )	3.4 ( 1.23 )	5.8 ( 1.26 )	13.0 ( 1.23 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-7.2

Confidence interval

level

90%

sides

2-sided

lower limit

-10.1

upper limit

-4.3

Variability estimate

Standard error of the mean

Dispersion value

1.75

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-9.5

Confidence interval

level

90%

sides

2-sided

lower limit

-12.4

upper limit

-6.7

Variability estimate

Standard error of the mean

Dispersion value

1.74

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

129

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-7.2

Confidence interval

level

90%

sides

2-sided

lower limit

-10.1

upper limit

-4.3

Variability estimate

Standard error of the mean

Dispersion value

1.76

Secondary: Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants

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End point title

Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 32 and 36

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	30	36	34	35
Units: ETDRS letters
arithmetic mean (standard error)	2.0 ( 1.31 )	3.4 ( 1.14 )	4.4 ( 1.20 )	8.5 ( 1.12 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0003

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-6.5

Confidence interval

level

90%

sides

2-sided

lower limit

-9.4

upper limit

-3.6

Variability estimate

Standard error of the mean

Dispersion value

1.73

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0022

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-5

Confidence interval

level

90%

sides

2-sided

lower limit

-7.7

upper limit

-2.4

Variability estimate

Standard error of the mean

Dispersion value

1.6

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0141

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-4.1

Confidence interval

level

90%

sides

2-sided

lower limit

-6.8

upper limit

-1.4

Variability estimate

Standard error of the mean

Dispersion value

1.64

Secondary: Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population

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End point title

Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population

End point description

The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. Overall ITT population included all randomized participants.

End point type

Secondary

End point timeframe

Baseline, Weeks 32 and 36

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	95	101	98	100
Units: ETDRS letters
arithmetic mean (standard error)	4.4 ( 0.93 )	3.6 ( 0.88 )	5.5 ( 0.91 )	11.4 ( 0.88 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

195

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-7

Confidence interval

level

90%

sides

2-sided

lower limit

-9.1

upper limit

-4.9

Variability estimate

Standard error of the mean

Dispersion value

1.28

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

201

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-7.8

Confidence interval

level

90%

sides

2-sided

lower limit

-9.9

upper limit

-5.8

Variability estimate

Standard error of the mean

Dispersion value

1.24

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

198

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-5.9

Confidence interval

level

90%

sides

2-sided

lower limit

-8

upper limit

-3.8

Variability estimate

Standard error of the mean

Dispersion value

1.27

Secondary: Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants

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End point title

Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants

End point description

The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. Treatment-naïve ITT population included all randomized participants who were naïve to IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization.

End point type

Secondary

End point timeframe

Baseline, Weeks 20 and 24

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	65	65	64	65
Units: ETDRS letters
arithmetic mean (standard error)	6.4 ( 1.19 )	3.5 ( 1.18 )	5.3 ( 1.20 )	11.1 ( 1.19 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0051

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-4.8

Confidence interval

level

90%

sides

2-sided

lower limit

-7.6

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

1.69

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

129

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0006

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-5.9

Confidence interval

level

90%

sides

2-sided

lower limit

-8.6

upper limit

-3.1

Variability estimate

Standard error of the mean

Dispersion value

1.69

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-7.6

Confidence interval

level

90%

sides

2-sided

lower limit

-10.4

upper limit

-4.8

Variability estimate

Standard error of the mean

Dispersion value

1.68

Secondary: Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants

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End point title

Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 20 and 24

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	30	36	34	35
Units: ETDRS letters
arithmetic mean (standard error)	2.7 ( 1.36 )	2.8 ( 1.19 )	5.4 ( 1.22 )	8.4 ( 1.18 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-5.7

Confidence interval

level

90%

sides

2-sided

lower limit

-8.7

upper limit

-2.7

Variability estimate

Standard error of the mean

Dispersion value

1.8

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0796

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-3

Confidence interval

level

90%

sides

2-sided

lower limit

-5.8

upper limit

-0.2

Variability estimate

Standard error of the mean

Dispersion value

1.7

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0012

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-5.6

Confidence interval

level

90%

sides

2-sided

lower limit

-8.4

upper limit

-2.8

Variability estimate

Standard error of the mean

Dispersion value

1.68

Secondary: Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population

Top of page

End point title

Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population

End point description

The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. Overall ITT population included all randomized participants.

End point type

Secondary

End point timeframe

Baseline, Weeks 20 and 24

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	95	101	98	100
Units: ETDRS letters
arithmetic mean (standard error)	5.1 ( 0.92 )	3.3 ( 0.87 )	5.4 ( 0.89 )	10.2 ( 0.88 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

195

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-5.1

Confidence interval

level

90%

sides

2-sided

lower limit

-7.2

upper limit

-3

Variability estimate

Standard error of the mean

Dispersion value

1.27

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

201

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-6.9

Confidence interval

level

90%

sides

2-sided

lower limit

-8.9

upper limit

-4.8

Variability estimate

Standard error of the mean

Dispersion value

1.24

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

198

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0002

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

-4.8

Confidence interval

level

90%

sides

2-sided

lower limit

-6.8

upper limit

-2.7

Variability estimate

Standard error of the mean

Dispersion value

1.25

Secondary: Change From Baseline in BCVA Over Time, in Overall Enrolled Population

Top of page

End point title

Change From Baseline in BCVA Over Time, in Overall Enrolled Population

End point description

The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported. Overall ITT population included all randomized participants. n= number of participants with data available for analysis at the specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	95	101	98	100
Units: ETDRS letters
arithmetic mean (standard error)
Change at Week 4 (n=89, 97, 94, 96)	3.0 ( 0.65 )	2.3 ( 0.63 )	3.8 ( 0.64 )	6.2 ( 0.63 )
Change at Week 8 (n=85, 96, 90, 93)	4.3 ( 0.68 )	3.3 ( 0.65 )	5.1 ( 0.66 )	7.6 ( 0.66 )
Change at Week 12 (n=78, 96, 87, 92)	4.4 ( 0.87 )	4.2 ( 0.82 )	4.6 ( 0.84 )	8.2 ( 0.83 )
Change at Week 16 (n=83, 92, 89, 88)	4.5 ( 0.85 )	3.7 ( 0.81 )	5.0 ( 0.83 )	9.1 ( 0.83 )
Change at Week 20 (n=78, 91, 83, 91)	5.2 ( 0.98 )	3.5 ( 0.92 )	5.0 ( 0.95 )	10.2 ( 0.93 )
Change at Week 24 (n=76, 85, 80, 85)	5.0 ( 0.93 )	3.2 ( 0.88 )	5.9 ( 0.90 )	10.3 ( 0.89 )
Change at Week 28 (n=74, 85, 74, 84)	4.6 ( 0.95 )	3.1 ( 0.90 )	5.3 ( 0.93 )	10.6 ( 0.91 )
Change at Week 32 (n=69, 79, 67, 87)	4.5 ( 0.95 )	3.4 ( 0.90 )	5.8 ( 0.94 )	11.3 ( 0.90 )
Change at Week 36 (n=69, 80, 69, 83)	4.2 ( 0.98 )	3.6 ( 0.92 )	5.2 ( 0.96 )	11.4 ( 0.92 )
Change at Week 40 (n=65, 70, 68, 82)	4.7 ( 1.25 )	2.3 ( 1.19 )	4.5 ( 1.22 )	11.8 ( 1.14 )
Change at Week 44 (n=64, 71, 66, 81)	5.3 ( 1.22 )	3.5 ( 1.16 )	4.3 ( 1.19 )	11.7 ( 1.12 )
Change at Week 48 (n=59, 67, 66, 83)	4.9 ( 1.22 )	2.9 ( 1.16 )	3.2 ( 1.19 )	11.5 ( 1.11 )
Change at Week 52 (n=53, 62, 64, 82)	4.8 ( 1.11 )	4.1 ( 1.05 )	4.7 ( 1.07 )	10.4 ( 1.01 )
Change at Week 56 (n=47, 60, 53, 76)	4.3 ( 1.34 )	2.5 ( 1.26 )	4.1 ( 1.30 )	9.8 ( 1.20 )
Change at Week 60 (n=46, 55, 50, 67)	4.3 ( 1.41 )	3.5 ( 1.32 )	3.3 ( 1.37 )	8.8 ( 1.25 )
Change at Week 64 (n=41, 54, 48, 54)	4.8 ( 1.45 )	3.7 ( 1.35 )	2.4 ( 1.40 )	9.2 ( 1.30 )
Change at Week 68 (n=40, 48, 44, 53)	5.6 ( 1.36 )	4.2 ( 1.28 )	2.9 ( 1.32 )	9.7 ( 1.22 )
Change at Week 72 (n=37, 47, 39, 47)	4.5 ( 1.39 )	3.6 ( 1.29 )	2.9 ( 1.35 )	9.2 ( 1.24 )

No statistical analyses for this end point

Secondary: Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population

Top of page

End point title

Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population

End point description

The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized. Overall ITT population included all randomized participants. Number analyzed is the number of participants with data available for analysis.

End point type

Secondary

End point timeframe

From baseline up to Week 72

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	94	100	98	98
Units: percentage of participants
number (not applicable)
Participants gaining ≥ 0 Letters	97.9	98.0	99.0	100
Participants gaining ≥ 5 Letters	79.8	83.0	76.5	94.9
Participants gaining ≥ 10 Letters	51.1	60.0	56.1	75.5
Participants gaining ≥ 15 Letters	26.6	28.0	34.7	58.2

No statistical analyses for this end point

Secondary: Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population

Top of page

End point title

Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population

End point description

The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized. Overall ITT population included all randomized participants. Number analyzed is the number of participants with data available for analysis.

End point type

Secondary

End point timeframe

From baseline up to Week 72

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	94	100	98	98
Units: percentage of participants
number (not applicable)
Participants avoiding a loss of ≥ 5 Letters	70.2	61.0	64.3	83.7
Participants avoiding a loss of ≥ 10 Letters	85.1	80.0	87.8	93.9
Participants avoiding a loss of ≥ 15 Letters	92.6	87.0	89.8	95.9

No statistical analyses for this end point

Secondary: Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population

Top of page

End point title

Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population

End point description

The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized. Overall ITT population included all randomized participants. n= number of participants with data available for analysis at the specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	95	101	98	100
Units: percentage of participants
number (not applicable)
Baseline (n=95, 101, 98, 100)	34.7	32.7	43.9	35.0
Week 1 (n=90, 97, 95, 97)	45.6	44.3	53.7	53.6
Week 4 (n=89, 97, 94, 96)	50.6	49.5	55.3	65.6
Week 8 (n=85, 96, 90, 93)	56.5	46.9	63.3	73.1
Week 12 (n=78, 96, 87, 92)	59.0	51.0	63.2	78.3
Week 16 (n=83, 92, 89, 88)	57.8	52.2	61.8	77.3
Week 20 (n=78, 91, 83, 91)	62.8	50.5	61.4	79.1
Week 24 (n=76, 85, 80, 85)	64.5	52.9	65.0	83.5
Week 28 (n=74, 85, 74, 84)	63.5	52.9	68.9	77.4
Week 32 (n=69, 79, 67, 87)	71.0	51.9	67.2	81.6
Week 36 (n=69, 80, 69, 83)	65.2	53.8	66.7	84.3
Week 40 (n=65, 70, 68, 82)	64.6	57.1	72.1	81.7
Week 44 (n=64, 71, 66, 81)	68.8	62.0	69.7	84.0
Week 48 (n=59, 67, 66, 83)	67.8	62.7	57.6	84.3
Week 52 (n=53, 62, 64, 82)	66.0	61.3	65.6	75.6
Week 56 (n=47, 60, 53, 76)	78.7	60.0	73.6	77.6
Week 60 (n=46, 55, 50, 67)	67.4	58.2	76.0	80.6
Week 64 (n=41, 54, 48, 54)	75.6	57.4	72.9	83.3
Week 68 (n=40, 48, 44, 53)	70.0	58.3	65.9	84.9
Week 72 (n=37, 47, 39, 47)	67.6	66.0	74.4	83.0

No statistical analyses for this end point

Secondary: Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population

Top of page

End point title

Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population

End point description

The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized. Overall ITT population included all randomized participants. n= number of participants with data available for analysis at the specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	95	101	98	100
Units: percentage of participants
number (not applicable)
Baseline (n=95, 101, 98, 100)	1.1	1.0	0	1.0
Week 1 (n=90, 97, 95, 97)	2.2	0	0	6.2
Week 4 (n=89, 97, 94, 96)	4.5	0	4.3	3.1
Week 8 (n=85, 96, 90, 93)	3.5	5.2	5.6	5.4
Week 12 (n=78, 96, 87, 92)	6.4	2.1	8.0	6.5
Week 16 (n=83, 92, 89, 88)	7.2	3.3	11.2	9.1
Week 20 (n=78, 91, 83, 91)	5.1	7.7	12.0	14.3
Week 24 (n=76, 85, 80, 85)	7.9	4.7	12.5	15.3
Week 28 (n=74, 85, 74, 84)	5.4	7.1	8.1	14.3
Week 32 (n=69, 79, 67, 87)	10.1	8.9	10.4	20.7
Week 36 (n=69, 80, 69, 83)	5.8	10.0	8.7	15.7
Week 40 (n=65, 70, 68, 82)	7.7	10.0	11.8	19.5
Week 44 (n=64, 71, 66, 81)	12.5	12.7	12.1	21.0
Week 48 (n=59, 67, 66, 83)	6.8	9.0	12.1	16.9
Week 52 (n=53, 62, 64, 82)	5.7	14.5	17.2	19.5
Week 56 (n=47, 60, 53, 76)	10.6	11.7	18.9	18.4
Week 60 (n=46, 55, 50, 67)	13.0	12.7	18.0	20.9
Week 64 (n=41, 54, 48, 54)	17.1	11.1	18.8	22.2
Week 68 (n=40, 48, 44, 53)	15.0	12.5	15.9	26.4
Week 72 (n=37, 47, 39, 47)	13.5	12.8	17.9	25.5

No statistical analyses for this end point

Secondary: Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population

Top of page

End point title

Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population

End point description

The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized. Overall ITT population included all randomized participants. n= number of participants with data available for analysis at the specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	95	101	98	100
Units: percentage of participants
number (not applicable)
Baseline (n=95, 101, 98, 100)	1.1	1.0	1.0	1.0
Week 1 (n=90, 97, 95, 97)	2.2	3.1	1.1	0
Week 4 (n=89, 97, 94, 96)	1.1	2.1	1.1	0
Week 8 (n=85, 96, 90, 93)	1.2	1.0	0	0
Week 12 (n=78, 96, 87, 92)	1.3	1.0	1.1	0
Week 16 (n=83, 92, 89, 88)	1.2	1.1	2.2	1.1
Week 20 (n=78, 91, 83, 91)	1.3	3.3	3.6	0
Week 24 (n=76, 85, 80, 85)	1.3	2.4	1.3	0
Week 28 (n=74, 85, 74, 84)	0	2.4	1.4	0
Week 32 (n=69, 79, 67, 87)	0	1.3	1.5	0
Week 36 (n=69, 80, 69, 83)	0	1.3	2.9	0
Week 40 (n=65, 70, 68, 82)	0	1.4	4.4	0
Week 44 (n=64, 71, 66, 81)	0	0	3.0	0
Week 48 (n=59, 67, 66, 83)	1.7	1.5	3.0	0
Week 52 (n=53, 62, 64, 82)	3.8	0	1.6	0
Week 56 (n=47, 60, 53, 76)	0	1.7	3.8	0
Week 60 (n=46, 55, 50, 67)	0	1.8	4.0	0
Week 64 (n=41, 54, 48, 54)	0	1.9	4.2	0
Week 68 (n=40, 48, 44, 53)	0	2.1	2.3	0
Week 72 (n=37, 47, 39, 47)	0	2.1	5.1	0

No statistical analyses for this end point

Secondary: Change From Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44 and 48, in Treatment-naïve Participants

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End point title

Change From Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44 and 48, in Treatment-naïve Participants

End point description

CST was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE), measured using Spectral Domain-Optical Coherence Tomography (SD-OCT). This analysis used a MMRM model. Adjusted mean has been reported. Treatment-naïve ITT population included all randomized participants who were naïve to IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization.

End point type

Secondary

End point timeframe

Baseline, Weeks 44 and 48

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	65	65	64	65
Units: micrometers (µm)
arithmetic mean (standard error)	-68.4 ( 14.23 )	-50.8 ( 14.18 )	-67.5 ( 14.44 )	-174.2 ( 13.95 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

105.8

Confidence interval

level

90%

sides

2-sided

lower limit

72.8

upper limit

138.7

Variability estimate

Standard error of the mean

Dispersion value

19.93

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

129

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

106.7

Confidence interval

level

90%

sides

2-sided

lower limit

73.5

upper limit

139.9

Variability estimate

Standard error of the mean

Dispersion value

20.09

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

123.3

Confidence interval

level

90%

sides

2-sided

lower limit

90.5

upper limit

156.2

Variability estimate

Standard error of the mean

Dispersion value

19.89

Secondary: Change From Baseline in CST Averaged Over Weeks 44 and 48, in Previously Treated Participants

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End point title

Change From Baseline in CST Averaged Over Weeks 44 and 48, in Previously Treated Participants

End point description

CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. Previously treated ITT population included all randomized participants who were previously treated with IVT anti-VEGF or periocular/IVT corticosteroids. Participants were grouped according to the treatment assigned at randomization.

End point type

Secondary

End point timeframe

Baseline, Weeks 44 and 48

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	30	36	34	35
Units: µm
arithmetic mean (standard error)	-40.9 ( 22.14 )	-81.4 ( 19.39 )	-75.8 ( 20.44 )	-185.7 ( 18.54 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

144.8

Confidence interval

level

90%

sides

2-sided

lower limit

96.8

upper limit

192.8

Variability estimate

Standard error of the mean

Dispersion value

28.89

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

109.9

Confidence interval

level

90%

sides

2-sided

lower limit

upper limit

155.8

Variability estimate

Standard error of the mean

Dispersion value

27.62

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0002

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

104.3

Confidence interval

level

90%

sides

2-sided

lower limit

59.7

upper limit

148.9

Variability estimate

Standard error of the mean

Dispersion value

26.82

Secondary: Change From Baseline in CST Averaged Over Weeks 44 and 48, in Overall Enrolled Population

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End point title

Change From Baseline in CST Averaged Over Weeks 44 and 48, in Overall Enrolled Population

End point description

CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. Overall ITT population included all randomized participants.

End point type

Secondary

End point timeframe

Baseline, Weeks 44 and 48

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	95	101	98	100
Units: µm
arithmetic mean (standard error)	-57.3 ( 12.14 )	-61.1 ( 11.64 )	-70.5 ( 11.97 )	-176.9 ( 11.32 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

195

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

119.7

Confidence interval

level

90%

sides

2-sided

lower limit

92.3

upper limit

147.1

Variability estimate

Standard error of the mean

Dispersion value

16.6

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

201

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

115.8

Confidence interval

level

90%

sides

2-sided

lower limit

89.1

upper limit

142.6

Variability estimate

Standard error of the mean

Dispersion value

16.23

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

198

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

106.4

Confidence interval

level

90%

sides

2-sided

lower limit

79.3

upper limit

133.6

Variability estimate

Standard error of the mean

Dispersion value

16.48

Secondary: Change From Baseline in CST Averaged Over Weeks 32 and 36, in Treatment-naïve Participants

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End point title

Change From Baseline in CST Averaged Over Weeks 32 and 36, in Treatment-naïve Participants

End point description

CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported. Treatment-naïve ITT population included all randomized participants who were naïve to IVT anti-VEGF or periocular/IVT corticosteroids treatment. Participants were grouped according to the treatment assigned at randomization.

End point type

Secondary

End point timeframe

Baseline, Weeks 32 and 36

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	65	65	64	65
Units: µm
arithmetic mean (standard error)	-57.1 ( 14.02 )	-46.9 ( 13.94 )	-64.8 ( 14.22 )	-163.9 ( 13.87 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

106.7

Confidence interval

level

90%

sides

2-sided

lower limit

74.2

upper limit

139.3

Variability estimate

Standard error of the mean

Dispersion value

19.72

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

117

Confidence interval

level

90%

sides

2-sided

lower limit

84.5

upper limit

149.5

Variability estimate

Standard error of the mean

Dispersion value

19.66

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

129

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

99.1

Confidence interval

level

90%

sides

2-sided

lower limit

66.3

upper limit

131.9

Variability estimate

Standard error of the mean

Dispersion value

19.87

Secondary: Change From Baseline in CST Averaged Over Weeks 32 and 36, in Previously Treated Participants

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End point title

Change From Baseline in CST Averaged Over Weeks 32 and 36, in Previously Treated Participants

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 32 and 36

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	30	36	34	35
Units: µm
arithmetic mean (standard error)	-35.4 ( 19.87 )	-90.5 ( 17.45 )	-81.5 ( 18.34 )	-168.5 ( 17.10 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

133.1

Confidence interval

level

90%

sides

2-sided

lower limit

89.5

upper limit

176.7

Variability estimate

Standard error of the mean

Dispersion value

26.23

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

37.3

upper limit

118.6

Variability estimate

Standard error of the mean

Dispersion value

24.41

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0008

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

Confidence interval

level

90%

sides

2-sided

lower limit

45.3

upper limit

128.8

Variability estimate

Standard error of the mean

Dispersion value

25.09

Secondary: Change From Baseline in CST Averaged Over Weeks 32 and 36, in Overall Enrolled Population

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End point title

Change From Baseline in CST Averaged Over Weeks 32 and 36, in Overall Enrolled Population

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 32 and 36

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	95	101	98	100
Units: µm
arithmetic mean (standard error)	-47.6 ( 11.57 )	-62.1 ( 11.09 )	-69.4 ( 11.41 )	-164.8 ( 10.95 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

195

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

117.2

Confidence interval

level

90%

sides

2-sided

lower limit

90.9

upper limit

143.5

Variability estimate

Standard error of the mean

Dispersion value

15.93

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

201

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

102.6

Confidence interval

level

90%

sides

2-sided

lower limit

76.9

upper limit

128.3

Variability estimate

Standard error of the mean

Dispersion value

15.58

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

198

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

95.3

Confidence interval

level

90%

sides

2-sided

lower limit

69.2

upper limit

121.4

Variability estimate

Standard error of the mean

Dispersion value

15.82

Secondary: Change From Baseline in CST Averaged Over Weeks 20 and 24, in Treatment-naïve Participants

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End point title

Change From Baseline in CST Averaged Over Weeks 20 and 24, in Treatment-naïve Participants

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 20 and 24

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	65	65	64	65
Units: µm
arithmetic mean (standard error)	-48.5 ( 11.61 )	-68.8 ( 11.53 )	-68.5 ( 11.62 )	-150.4 ( 11.56 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

101.9

Confidence interval

level

90%

sides

2-sided

lower limit

74.9

upper limit

129

Variability estimate

Standard error of the mean

Dispersion value

16.38

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

130

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

81.5

Confidence interval

level

90%

sides

2-sided

lower limit

54.6

upper limit

108.5

Variability estimate

Standard error of the mean

Dispersion value

16.32

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

129

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

81.9

Confidence interval

level

90%

sides

2-sided

lower limit

54.8

upper limit

109

Variability estimate

Standard error of the mean

Dispersion value

16.4

Secondary: Change From Baseline in CST Averaged Over Weeks 20 and 24, in Previously Treated Participants

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End point title

Change From Baseline in CST Averaged Over Weeks 20 and 24, in Previously Treated Participants

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 20 and 24

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	30	36	34	35
Units: µm
arithmetic mean (standard error)	-5.7 ( 20.88 )	-81.7 ( 18.67 )	-68.7 ( 19.22 )	-146.4 ( 18.47 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

140.6

Confidence interval

level

90%

sides

2-sided

lower limit

94.3

upper limit

186.9

Variability estimate

Standard error of the mean

Dispersion value

27.89

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0157

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

64.6

Confidence interval

level

90%

sides

2-sided

lower limit

upper limit

108.2

Variability estimate

Standard error of the mean

Dispersion value

26.25

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0045

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

77.7

Confidence interval

level

90%

sides

2-sided

lower limit

33.4

upper limit

122

Variability estimate

Standard error of the mean

Dispersion value

26.67

Secondary: Change From Baseline in CST Averaged Over Weeks 20 and 24, in Overall Enrolled Population

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End point title

Change From Baseline in CST Averaged Over Weeks 20 and 24, in Overall Enrolled Population

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 20 and 24

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	95	101	98	100
Units: µm
arithmetic mean (standard error)	-36.1 ( 10.28 )	-72.9 ( 9.88 )	-69.0 ( 10.01 )	-148.1 ( 9.86 )

Arm A vs Arm D

Comparison groups

Arm A: Vamikibart 0.25 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

195

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

112

Confidence interval

level

90%

sides

2-sided

lower limit

88.5

upper limit

135.5

Variability estimate

Standard error of the mean

Dispersion value

14.25

Arm B vs Arm D

Comparison groups

Arm B: Vamikibart 1 mg Q8W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

201

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

75.2

Confidence interval

level

90%

sides

2-sided

lower limit

52.1

upper limit

98.2

Variability estimate

Standard error of the mean

Dispersion value

13.95

Arm C vs Arm D

Comparison groups

Arm C: Vamikibart 1 mg Q4W v Arm D: Ranibizumab 0.5 mg Q4W

Number of subjects included in analysis

198

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

MMRM

Parameter type

Difference in Adjusted Means

Point estimate

79.1

Confidence interval

level

90%

sides

2-sided

lower limit

55.9

upper limit

102.3

Variability estimate

Standard error of the mean

Dispersion value

14.06

Secondary: Change From Baseline in CST Over Time, in Overall Enrolled Population

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End point title

Change From Baseline in CST Over Time, in Overall Enrolled Population

End point description

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	95	101	98	100
Units: µm
arithmetic mean (standard error)
Change at Week 4 (n=88, 94, 93, 96)	-25.7 ( 8.06 )	-26.6 ( 7.88 )	-36.3 ( 7.93 )	-106.9 ( 7.83 )
Change at Week 8 (n=85, 94, 89, 92)	-31.2 ( 9.02 )	-34.0 ( 8.76 )	-50.9 ( 8.87 )	-130.7 ( 8.76 )
Change at Week 12 (n=79, 93, 86, 92)	-38.4 ( 9.66 )	-52.9 ( 9.27 )	-56.3 ( 9.41 )	-131.4 ( 9.27 )
Change at Week 16 (n=83, 90, 88, 88)	-39.3 ( 10.43 )	-55.0 ( 10.06 )	-59.5 ( 10.16 )	-138.8 ( 10.08 )
Change at Week 20 (n=78, 88, 82, 90)	-37.9 ( 10.88 )	-71.5 ( 10.44 )	-64.0 ( 10.59 )	-139.9 ( 10.41 )
Change at Week 24 (n=76, 83, 79, 85)	-30.7 ( 10.73 )	-71.4 ( 10.31 )	-69.7 ( 10.46 )	-152.4 ( 10.27 )
Change at Week 28 (n=73, 83, 73, 84)	-47.3 ( 11.36 )	-66.7 ( 10.87 )	-67.3 ( 11.14 )	-158.9 ( 10.81 )
Change at Week 32 (n=70, 78, 66, 87)	-47.2 ( 11.82 )	-59.6 ( 11.33 )	-69.6 ( 11.66 )	-159.2 ( 11.18 )
Change at Week 36 (n=70, 79, 67, 83)	-44.2 ( 12.07 )	-61.6 ( 11.56 )	-64.8 ( 11.93 )	-166.8 ( 11.40 )
Change at Week 40 (n=66, 69, 67, 82)	-50.3 ( 12.51 )	-56.1 ( 12.03 )	-69.7 ( 12.34 )	-164.2 ( 11.74 )
Change at Week 44 (n=64, 70, 64, 81)	-53.5 ( 12.26 )	-56.4 ( 11.75 )	-73.6 ( 12.11 )	-174.4 ( 11.44 )
Change at Week 48 (n=60, 66, 65, 83)	-58.4 ( 12.76 )	-62.2 ( 12.24 )	-63.1 ( 12.52 )	-176.2 ( 11.82 )
Change at Week 52 (n=53, 60, 63, 82)	-63.4 ( 13.52 )	-72.0 ( 12.89 )	-89.6 ( 13.01 )	-112.4 ( 11.92 )
Change at Week 56 (n=47, 59, 53, 77)	-67.6 ( 14.94 )	-81.6 ( 13.84 )	-74.6 ( 14.36 )	-107.3 ( 12.66 )
Change at Week 60 (n=46, 54, 50, 67)	-73.9 ( 14.17 )	-77.2 ( 13.41 )	-81.5 ( 13.69 )	-111.0 ( 12.34 )
Change at Week 64 (n=41, 53, 48, 55)	-66.1 ( 14.20 )	-66.3 ( 13.31 )	-81.1 ( 13.65 )	-112.5 ( 12.48 )
Change at Week 68 (n=40, 46, 43, 53)	-73.2 ( 14.64 )	-88.8 ( 13.81 )	-65.4 ( 14.13 )	-115.2 ( 12.87 )
Change at Week 72 (n=37, 46, 39, 46)	-73.9 ( 14.28 )	-81.9 ( 13.45 )	-78.8 ( 13.83 )	-113.1 ( 12.61 )

No statistical analyses for this end point

Secondary: Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population

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End point title

Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population

End point description

Absence of DME was defined as CST < 325 µm for spectralis SD-OCT, or < 315 μm for cirrus SD-OCT or topcon SD-OCT. SD-OCT was performed on a Spectralis instrument. Percentages have been summarized. Overall ITT population included all randomized participants. n= number of participants with data available for analysis at the specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	95	101	98	100
Units: percentage of participants
number (confidence interval 95%)
Baseline (n=95, 98, 97, 100)	3.2 (0.0 to 6.7)	1.0 (0.0 to 3.0)	4.1 (0.2 to 8.1)	6.0 (1.3 to 10.7)
Week 4 (n=88, 95, 94, 96)	6.8 (1.6 to 12.1)	8.4 (2.8 to 14.0)	13.8 (6.9 to 20.8)	35.4 (25.8 to 45.0)
Week 8 (n=85, 96, 90, 92)	10.6 (4.0 to 17.1)	12.5 (5.9 to 19.1)	17.8 (9.9 to 25.7)	53.3 (43.1 to 63.5)
Week 12 (n=79, 95, 87, 92)	8.9 (2.6 to 15.1)	18.9 (11.1 to 26.8)	24.1 (15.1 to 33.1)	53.3 (43.1 to 63.5)
Week 16 (n=83, 92, 89, 88)	12.0 (5.0 to 19.1)	16.3 (8.8 to 23.9)	25.8 (16.7 to 34.9)	61.4 (51.2 to 71.5)
Week 20 (n=78, 90, 83, 90)	19.2 (10.5 to 28.0)	27.8 (18.5 to 37.0)	30.1 (20.3 to 40.0)	64.4 (54.6 to 74.3)
Week 24 (n=76, 85, 80, 85)	17.1 (8.6 to 25.6)	25.9 (16.6 to 35.2)	26.3 (16.6 to 35.9)	70.6 (60.9 to 80.3)
Week 28 (n=73, 85, 74, 84)	24.7 (14.8 to 34.5)	29.4 (19.7 to 39.1)	33.8 (23.0 to 44.6)	73.8 (64.4 to 83.2)
Week 32 (n=70, 80, 67, 87)	35.7 (24.5 to 46.9)	28.8 (18.8 to 38.7)	34.3 (23.0 to 45.7)	75.9 (66.9 to 84.9)
Week 36 (n=70, 80, 68, 83)	30.0 (19.3 to 40.7)	31.3 (21.1 to 41.4)	35.3 (23.9 to 46.7)	79.5 (70.8 to 88.2)
Week 40 (n=66, 70, 68, 82)	33.3 (22.0 to 44.7)	27.1 (16.7 to 37.6)	35.3 (23.9 to 46.7)	78.0 (69.1 to 87.0)
Week 44 (n=64, 71, 65, 81)	34.4 (22.7 to 46.0)	33.8 (22.8 to 44.8)	35.4 (23.8 to 47.0)	80.2 (71.6 to 88.9)
Week 48 (n=60, 67, 65, 83)	41.7 (29.2 to 54.1)	35.8 (24.3 to 47.3)	30.8 (19.5 to 42.0)	79.5 (70.8 to 88.2)
Week 52 (n=53, 61, 63, 82)	35.8 (22.9 to 48.8)	39.3 (27.1 to 51.6)	36.5 (24.6 to 48.4)	54.9 (44.1 to 65.6)
Week 56 (n=47, 60, 53, 77)	36.2 (22.4 to 49.9)	41.7 (29.2 to 54.1)	45.3 (31.9 to 58.7)	59.7 (48.8 to 70.7)
Week 60 (n=46, 55, 50, 67)	47.8 (33.4 to 62.3)	41.8 (28.8 to 54.9)	50.0 (36.1 to 63.9)	61.2 (49.5 to 72.9)
Week 64 (n=41, 54, 48, 55)	48.8 (33.5 to 64.1)	48.1 (34.8 to 61.5)	47.9 (33.8 to 62.0)	61.8 (49.0 to 74.7)
Week 68 (n=40, 47, 43, 53)	45.0 (29.6 to 60.4)	51.1 (36.8 to 65.4)	48.8 (33.9 to 63.8)	62.3 (49.2 to 75.3)
Week 72 (n=37, 47, 39, 46)	43.2 (27.3 to 59.2)	42.6 (28.4 to 56.7)	48.7 (33.0 to 64.4)	60.9 (46.8 to 75.0)

No statistical analyses for this end point

Secondary: Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled Population

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End point title

Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled Population

End point description

The absence of IRF in the study eye (defined as IRF absent or definite outside center subfield only) was assessed by the central reading center using SD-OCT. The percentage of participants with absence of IRF at foveal center were reported. Percentages have been summarized. Overall ITT population included all randomized participants. n= number of participants with data available for analysis at the specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 12, 24, 36, 48, and 72

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	95	101	98	100
Units: percentage of participants
number (not applicable)
Baseline (n=95,99,97,100)	22.1	15.2	24.7	25.0
Week 4 (n=88,94,93,96)	21.6	26.6	32.3	46.9
Week 12 (n=77,95,84,91)	33.8	40.0	38.1	56.0
Week 24 (n=75,84,78,84)	34.7	45.2	53.8	64.3
Week 36 (n=66,78,66,81)	42.4	43.6	43.9	84.0
Week 48 (n=59,67,63,81)	49.2	47.8	44.4	77.8
Week 72 (n=37,47,39,46)	62.2	55.3	61.5	76.1

No statistical analyses for this end point

Secondary: Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time, in Overall ITT Population

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End point title

Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time, in Overall ITT Population

End point description

The absence of SRF in the study eye (defined as SRF absent or definite outside center subfield only) was assessed by the central reading center using SD-OCT. The percentage of participants with absence of SRF at the foveal center were reported. Percentages have been summarized. Overall ITT population included all randomized participants. n= number of participants with data available for analysis at the specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Weeks 4, 12, 24, 36, 48, and 72

End point values	Arm A: Vamikibart 0.25 mg Q8W	Arm B: Vamikibart 1 mg Q8W	Arm C: Vamikibart 1 mg Q4W	Arm D: Ranibizumab 0.5 mg Q4W
Number of subjects analysed	95	101	98	100
Units: percentage of participants
number (not applicable)
Baseline (n=95,99,97,100)	62.1	61.6	68.0	67.0
Week 4 (n=88,95,93,96)	70.5	71.6	82.8	85.4
Week 12 (n=77,95,85,91)	81.8	77.9	87.1	96.7
Week 24 (n=75,84,79,84)	84.0	89.3	88.6	97.6
Week 36 (n=66,78,66,81)	87.9	89.7	93.9	100
Week 48 (n=59,67,63,81)	89.8	91.0	93.7	98.8
Week 72 (n=37,47,39,46)	94.6	93.6	97.4	95.7

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From baseline up to 72 weeks

Adverse event reporting additional description

Safety analysis population included all participants randomized to study treatment & who received at least one dose of the study treatment, whether prematurely withdrawn from study or not. Participants were grouped according to actual treatment received. Ocular AEs included both study eye & fellow eye.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

28.0

Reporting group title

Arm A: Vamikibart 0.25 mg Q8W

Reporting group description

Participants received vamikibart, 0.25 mg, IVT injection in the specified study eye on Day 1 and Q8W for a total of 6 injections up to Week 44. A sham procedure was administered to participants at applicable visits to maintain masking between treatment arms. After Week 44, participants were followed for safety up to Week 72.

Reporting group title

Arm D: Ranibizumab 0.5 mg Q4W

Reporting group description

Reporting group title

Arm C: Vamikibart 1 mg Q4W

Reporting group description

Reporting group title

Arm B: Vamikibart 1 mg Q8W

Reporting group description

Serious adverse events	Arm A: Vamikibart 0.25 mg Q8W	Arm D: Ranibizumab 0.5 mg Q4W	Arm C: Vamikibart 1 mg Q4W	Arm B: Vamikibart 1 mg Q8W
Total subjects affected by serious adverse events
subjects affected / exposed	17 / 94 (18.09%)	20 / 98 (20.41%)	21 / 98 (21.43%)	25 / 100 (25.00%)
number of deaths (all causes)	1	1	1	1
number of deaths resulting from adverse events	1	1	1	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	0 / 98 (0.00%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Aortic stenosis
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypertension
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	1 / 98 (1.02%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypertensive crisis
subjects affected / exposed	1 / 94 (1.06%)	0 / 98 (0.00%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypotension
subjects affected / exposed	1 / 94 (1.06%)	0 / 98 (0.00%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Peripheral arterial occlusive disease
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	1 / 94 (1.06%)	0 / 98 (0.00%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Generalised oedema
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Death
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
subjects affected / exposed	1 / 94 (1.06%)	0 / 98 (0.00%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	0 / 98 (0.00%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Asthma
subjects affected / exposed	0 / 94 (0.00%)	2 / 98 (2.04%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Blood pressure increased
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Eye injury
subjects affected / exposed	1 / 94 (1.06%)	0 / 98 (0.00%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	1 / 94 (1.06%)	1 / 98 (1.02%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	1 / 94 (1.06%)	0 / 98 (0.00%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lower limb fracture
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	1 / 98 (1.02%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ischaemic cardiomyopathy
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	2 / 94 (2.13%)	0 / 98 (0.00%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
Ventricular extrasystoles
subjects affected / exposed	1 / 94 (1.06%)	0 / 98 (0.00%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	3 / 98 (3.06%)	2 / 100 (2.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
Dizziness
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	0 / 98 (0.00%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Cataract nuclear
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	0 / 98 (0.00%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bullous keratopathy
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eye inflammation
subjects affected / exposed	1 / 94 (1.06%)	0 / 98 (0.00%)	0 / 98 (0.00%)	2 / 100 (2.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Glaucoma
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ocular vasculitis
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	0 / 98 (0.00%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Iridocyclitis
subjects affected / exposed	1 / 94 (1.06%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Retinal occlusive vasculitis
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	2 / 98 (2.04%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Rhegmatogenous retinal detachment
subjects affected / exposed	1 / 94 (1.06%)	0 / 98 (0.00%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tractional retinal detachment
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Uveitis
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	3 / 98 (3.06%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	2 / 5	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Visual acuity reduced
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	0 / 98 (0.00%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vitreous haemorrhage
subjects affected / exposed	0 / 94 (0.00%)	2 / 98 (2.04%)	1 / 98 (1.02%)	3 / 100 (3.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vitritis
subjects affected / exposed	1 / 94 (1.06%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Colitis
subjects affected / exposed	1 / 94 (1.06%)	0 / 98 (0.00%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hernial eventration
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Bile duct stone
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	0 / 98 (0.00%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	1 / 94 (1.06%)	0 / 98 (0.00%)	0 / 98 (0.00%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Diabetic foot
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	1 / 94 (1.06%)	1 / 98 (1.02%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Chronic kidney disease
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	2 / 98 (2.04%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
End stage renal disease
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	2 / 98 (2.04%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal failure
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	0 / 98 (0.00%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	0 / 98 (0.00%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Abscess limb
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
COVID-19
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Chorioretinitis
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Corneal abscess
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	0 / 98 (0.00%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eye infection toxoplasmal
subjects affected / exposed	1 / 94 (1.06%)	0 / 98 (0.00%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infected skin ulcer
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infective exacerbation of asthma
subjects affected / exposed	1 / 94 (1.06%)	0 / 98 (0.00%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Influenza
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	0 / 98 (0.00%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	1 / 98 (1.02%)	4 / 100 (4.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Localised infection
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	1 / 98 (1.02%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	1 / 98 (1.02%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 94 (0.00%)	2 / 98 (2.04%)	0 / 98 (0.00%)	2 / 100 (2.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Diabetic complication
subjects affected / exposed	0 / 94 (0.00%)	1 / 98 (1.02%)	0 / 98 (0.00%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Fluid retention
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	1 / 94 (1.06%)	1 / 98 (1.02%)	1 / 98 (1.02%)	0 / 100 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	0 / 94 (0.00%)	0 / 98 (0.00%)	0 / 98 (0.00%)	1 / 100 (1.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Arm A: Vamikibart 0.25 mg Q8W	Arm D: Ranibizumab 0.5 mg Q4W	Arm C: Vamikibart 1 mg Q4W	Arm B: Vamikibart 1 mg Q8W
Total subjects affected by non serious adverse events
subjects affected / exposed	25 / 94 (26.60%)	32 / 98 (32.65%)	36 / 98 (36.73%)	40 / 100 (40.00%)
Vascular disorders
Hypertension
subjects affected / exposed	6 / 94 (6.38%)	7 / 98 (7.14%)	5 / 98 (5.10%)	8 / 100 (8.00%)
occurrences all number	6	7	6	8
Eye disorders
Cataract
subjects affected / exposed	1 / 94 (1.06%)	9 / 98 (9.18%)	5 / 98 (5.10%)	7 / 100 (7.00%)
occurrences all number	1	12	10	9
Conjunctival haemorrhage
subjects affected / exposed	6 / 94 (6.38%)	6 / 98 (6.12%)	6 / 98 (6.12%)	10 / 100 (10.00%)
occurrences all number	6	9	8	10
Diabetic retinal oedema
subjects affected / exposed	7 / 94 (7.45%)	5 / 98 (5.10%)	12 / 98 (12.24%)	10 / 100 (10.00%)
occurrences all number	7	6	12	13
Diabetic retinopathy
subjects affected / exposed	5 / 94 (5.32%)	2 / 98 (2.04%)	4 / 98 (4.08%)	2 / 100 (2.00%)
occurrences all number	5	2	5	2
Vitreous haemorrhage
subjects affected / exposed	3 / 94 (3.19%)	4 / 98 (4.08%)	6 / 98 (6.12%)	6 / 100 (6.00%)
occurrences all number	3	4	6	7
Infections and infestations
COVID-19
subjects affected / exposed	2 / 94 (2.13%)	4 / 98 (4.08%)	3 / 98 (3.06%)	6 / 100 (6.00%)
occurrences all number	2	4	3	6
Nasopharyngitis
subjects affected / exposed	2 / 94 (2.13%)	5 / 98 (5.10%)	4 / 98 (4.08%)	2 / 100 (2.00%)
occurrences all number	2	5	4	2

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Were there any global substantial amendments to the protocol? Yes

11 Jul 2022

- Vamikibart administration was extended from Week 24 to Week 48. - The objectives and endpoints (including the primary endpoint), schedule of activities, and anticipated study duration were updated to reflect the extended dosing. - The role of masked assessors was clarified. - Participants previously treated with faricimab could be enrolled after an appropriate washout period.

23 Apr 2023

- Following the report of occlusive retinal vascular AEs in the study eye, certain modifications were implemented to mitigate the risk of such events, including changes to the criteria for stopping further treatment in cases of intraocular inflammation (IOI), and changes to study exclusion criteria. - Overall safety measures for assessment of early signs of IOI were added.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase II, Multicenter, Randomized, Double Masked, Active Comparator-controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients With Diabetic Macular Edema

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Treatment-naïve Participants

Primary: Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Treatment-naïve Participants

Secondary: Number of Participants With Systemic and Ocular Adverse Events (AEs)

Secondary: Number of Participants With Systemic and Ocular Adverse Events (AEs)

Secondary: Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants

Secondary: Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants

Secondary: Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population

Secondary: Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population

Secondary: Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants

Secondary: Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants

Secondary: Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants

Secondary: Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants

Secondary: Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population

Secondary: Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population

Secondary: Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants

Secondary: Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants

Secondary: Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants

Secondary: Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants

Secondary: Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population

Secondary: Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population

Secondary: Change From Baseline in BCVA Over Time, in Overall Enrolled Population

Secondary: Change From Baseline in BCVA Over Time, in Overall Enrolled Population

Secondary: Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population

Secondary: Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population

Secondary: Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population

Secondary: Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population

Secondary: Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population

Secondary: Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population

Secondary: Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population

Secondary: Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population

Secondary: Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population

Secondary: Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population

Secondary: Change From Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44 and 48, in Treatment-naïve Participants

Secondary: Change From Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44 and 48, in Treatment-naïve Participants

Secondary: Change From Baseline in CST Averaged Over Weeks 44 and 48, in Previously Treated Participants

Secondary: Change From Baseline in CST Averaged Over Weeks 44 and 48, in Previously Treated Participants

Secondary: Change From Baseline in CST Averaged Over Weeks 44 and 48, in Overall Enrolled Population

Secondary: Change From Baseline in CST Averaged Over Weeks 44 and 48, in Overall Enrolled Population

Secondary: Change From Baseline in CST Averaged Over Weeks 32 and 36, in Treatment-naïve Participants

Secondary: Change From Baseline in CST Averaged Over Weeks 32 and 36, in Treatment-naïve Participants

Secondary: Change From Baseline in CST Averaged Over Weeks 32 and 36, in Previously Treated Participants

Secondary: Change From Baseline in CST Averaged Over Weeks 32 and 36, in Previously Treated Participants

Secondary: Change From Baseline in CST Averaged Over Weeks 32 and 36, in Overall Enrolled Population

Secondary: Change From Baseline in CST Averaged Over Weeks 32 and 36, in Overall Enrolled Population

Secondary: Change From Baseline in CST Averaged Over Weeks 20 and 24, in Treatment-naïve Participants

Secondary: Change From Baseline in CST Averaged Over Weeks 20 and 24, in Treatment-naïve Participants

Secondary: Change From Baseline in CST Averaged Over Weeks 20 and 24, in Previously Treated Participants

Secondary: Change From Baseline in CST Averaged Over Weeks 20 and 24, in Previously Treated Participants

Secondary: Change From Baseline in CST Averaged Over Weeks 20 and 24, in Overall Enrolled Population

Secondary: Change From Baseline in CST Averaged Over Weeks 20 and 24, in Overall Enrolled Population

Secondary: Change From Baseline in CST Over Time, in Overall Enrolled Population

Secondary: Change From Baseline in CST Over Time, in Overall Enrolled Population

Secondary: Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population

Secondary: Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population

Secondary: Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled Population

Secondary: Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled Population

Secondary: Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time, in Overall ITT Population

Secondary: Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time, in Overall ITT Population

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase II, Multicenter, Randomized, Double Masked, Active Comparator-controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients With Diabetic Macular Edema